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The Region of the Americas makes progress in drowning prevention, but challenges remain
The Region of the Americas makes progress in drowning prevention, but challenges remain
Oscar Reyes
15 Sep 2025
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Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.
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Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery
t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that makes the pump stop delivering insulin.
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BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets
FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc
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FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products
http://www.fda.gov/news-events/press-announcements/fda-launches-real-time-adverse-event-reporting-dashboard-cosmetic-products
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Update on Alert: Defibrillation Lead Issue from Boston Scientific
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
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Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.
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Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication
Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.
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HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation
HHS, CBP Seize $86.5 Million Worth of Illegal E-Cigarettes in Largest-Ever Operation
http://www.fda.gov/news-events/press-announcements/hhs-cbp-seize-865-million-worth-illegal-e-cigarettes-largest-ever-operation
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FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse
FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse
http://www.fda.gov/news-events/press-announcements/fda-issues-new-guidance-expand-non-opioid-options-chronic-pain-curb-misuse
